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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-0399

2. Registrant Information.

Registrant Reference Number: 2020-US-043261

Registrant Name (Full Legal Name no abbreviations): The Hartz Mountain Corporation

Address: 400 Plaza Drive

City: Secaucus

Prov / State: New Jersey

Country: USA

Postal Code: 07094-3688

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

03-DEC-20

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW JERSEY

6. Date incident was first observed.

17-NOV-20

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2596-139

Product Name: Hartz UltraGuard Pro Flea and Tick Collar (non-specific)

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 1.02 %
    • TETRACHLORVINPHOS
      • Guarantee/concentration 14.55 %

7. b) Type of formulation.

Other (specify)

Collar

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Animal / Usage sur un animal domestique

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.58

7. Weight (provide a range if necessary )

7

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Seizure
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On 10-Nov-2020, a 7 month old, 7 pound, intact, female, Domestic Shorthair cat, in unknown condition, with concomitant medical condition of fleas, was administered 1 collar of Hartz UltraGuard Pro Flea and Tick Collar (non-specific) (Tetrachlorvinphos (Rabon) / S Methoprene) via the topical route by the animal owner. The animal owner suspected the cat may have been pregnant at the time of product application. On 17-Nov-2020, the cat developed ataxia, seizures, and then died. The cat was not evaluated by a veterinarian and no treatments were performed. It is unknown if a necropsy was performed. No further information was received in this case.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

Assessment: This product has a wide margin of safety in cats following labeled use. If some product residue was ingested, mild GI upset may occur. The onset of signs 1 week post-application is unusual and severe signs progressing to death do not fit the toxicological profile of the product. Other causes including unknown trauma, toxin exposure, congenital conditions, infectious diseases, and severe flea anemia should be considered following sudden death in a young cat. Without diagnostics, this case cannot be evaluated further. The information contained in this report is based on self-reported statements provided to the registrant during telephone interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and cannot form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.